Assistance Publique Hopitaux de Marseille
Marseille, 13354, France
Completed
NCT Number: NCT01957228
Causative Diagnosis on Prosthetic Joint Infections: Establishment of a Comprehensive Diagnostic Strategy
On joint orthopaedic hardware infections are one of the most frequently encountered complications in orthopaedic surgery. However 6% of the cultures remain sterile, etiological diagnosis cannot be established despite obvious signs of infection. As part of this research project, we have developed a new strategy diagnosis including directly the use of PCR to reduce the number of negative results. This should have a major therapeutic impact in terms of timeliness and specificity of antibiotic.
Primary:
Evaluate the effectiveness of the new diagnostic strategy on etiological identification of prosthesis infections.
Hypothesis:
Minimum 6 percent increase in the number of patients with an etiological diagnosis of infection on prosthesis.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patient is more than 18 years old.
- Patient with a prescription of a microbiologic diagnostic of Prosthetic joint infection
- Patient who do not declined to have his medical records reviewed for research
- Patient with health insurance
Exclusion criteria
- Patient minor (<18 years).
- Pregnant or lactating woman.
- Major under guardianship Patient.
- Patient deprived of liberty or under court order
Treatment and study plan
bone biopsies
ProcedurePrimary outcomes
-
Bone biopsies multisite
Time frame: 4 years
Increase of at least 6% of patients with an etiologic diagnosis of prosthesis infection established.
Sponsors and collaborators
Lead sponsor
Assistance Publique Hopitaux De Marseille
Other
Registry information
Important dates
- Study start
- 2013
- Primary completion
- 2019
- Study completion
- 2022
- First posted
- Oct 8, 2013
- Registry last updated
- Apr 21, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.